Obesity & OverweightBEYONDNCT07455630
Cardiac Function and Biomarkers in Patients With Obesity and Overweight
An observational study of Obesity & Overweight, run by TecSalud Investigación Clínica at 1 site in Mexico.
Trial summary
Obesity is a major public health problem worldwide and an established risk factor for cardiovascular disease. In individuals with obesity or overweight, systemic inflammation and endothelial dysfunction contribute to myocardial hypertrophy, ventricular remodeling, and alterations in cardiac morphology and function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Weight loss with pharmacotherapy and Weight loss without pharmacotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- 20 Jun 2023to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with overweight or obesity and at least one cardiovascular risk factor who have been prescribed a pharmacologic or non-pharmacologic weight reduction strategy.
Who may be able to join
- Age >= 18 years
- BMI > 25 kg/m2
- At least one cardiovascular risk factor
- Has been prescribed a pharmacologic or non-pharmacologic weight loss strategy
- Signed informed consent
Who cannot join
- No weight loss strategy prescribed
- No cardiovascular risk factors
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Zambrano Hellion, TecSalud
San Pedro Garza García, Nuevo León, 66278
About this study
Official title: Effect of Weight Loss on Cardiac Function and Biomarkers in Patients With Cardiovascular Risk Factors, Obesity, or Overweight
Obesity is a major public health problem worldwide and an established risk factor for cardiovascular disease. In individuals with obesity or overweight, systemic inflammation and endothelial dysfunction contribute to myocardial hypertrophy, ventricular remodeling, and alterations in cardiac morphology and function. Weight loss has been shown to improve metabolic and hemodynamic parameters; however, evidence regarding structural and functional cardiac reversibility remains limited.
This prospective single-center cohort study aims to evaluate changes in cardiac morphology and function (assessed by cardiac magnetic resonance imaging and echocardiography), as well as changes in inflammatory and cardiac biomarkers, in patients with obesity or overweight and cardiovascular risk factors who achieve at least a 10% reduction in body weight through pharmacological or non-pharmacological interventions.
Read the detailed description
Obesity is one of the leading global health issues, with a high impact on morbidity, mortality, and quality of life. In Mexico, the prevalence of obesity has significantly increased in the past two decades, ranking fifth worldwide. Obesity is strongly associated with other cardiovascular risk factors, including hypertension, diabetes, and dyslipidemia.
In obese individuals, a chronic low-grade inflammatory state and endothelial dysfunction contribute to adverse cardiovascular remodeling. These mechanisms-driven by adipose tissue inflammation, reduced nitric oxide bioavailability, and insulin resistance-can lead to myocardial hypertrophy, ventricular dilation, and impaired cardiac function. Structural and functional changes include increased left ventricular mass, larger right and left ventricular end-diastolic volumes, and subclinical diastolic dysfunction, as demonstrated by echocardiography and cardiac magnetic resonance imaging (MRI). Obesity-related adipose tissue dysfunction also induces an imbalance between anti-inflammatory adiponectin and pro-inflammatory adipocytokines, promoting myocardial and vascular remodeling.
Furthermore, epicardial adipose tissue exhibits high immune cell activity, including elevated expression of IL-1, IL-6, and TNF-α, contributing to the pathophysiology of heart failure with preserved ejection fraction (HFpEF). Alterations in gut microbiota (dysbiosis) also play a role in obesity-related inflammation by producing bacterial metabolites and lipopolysaccharides associated with endothelial activation and atherosclerotic plaque instability. Pharmacological interventions such as GLP-1 receptor agonists and SGLT2 inhibitors have shown potential benefits in reducing inflammation and improving cardiac metabolism. Weight loss-whether achieved through lifestyle modification, pharmacotherapy, or bariatric surgery-has been associated with improvements in hemodynamic load, blood pressure, and metabolic parameters. However, evidence regarding the reversibility of cardiac structural and functional changes remains insufficient. This study will prospectively evaluate adult patients (≥18 years) with overweight (BMI ≥25 kg/m²) or obesity (BMI ≥30 kg/m²) and at least one cardiovascular risk factor. Participants will receive individualized nutritional counseling and weight loss interventions (pharmacological or non-pharmacological) according to standard clinical practice at the TecSalud Institute of Cardiology and Vascular Medicine.
The primary objective is to determine whether significant weight loss (>10% reduction in body weight) results in measurable changes in cardiac morphology and function assessed by cardiac MRI and echocardiography. Secondary objectives include evaluating changes in inflammatory and cardiac biomarkers. An exploratory analysis will assess differences according to the weight loss strategy (pharmacological vs. non-pharmacological), including possible associations with gut microbiota composition. Ultimately, this study seeks to provide new evidence on the reversibility of obesity-related cardiac changes and the potential role of inflammatory and metabolic biomarkers in cardiovascular risk reduction.
- Conditions
- Obesity & Overweight
- Being tested
- Weight loss with pharmacotherapy, Weight loss without pharmacotherapy
- Keywords
- Cardiovascular risk, Cardiac Function, Cardiac MRI, Echocardiography, Inflammation, Weight loss, GLP-1 receptor agonists
- Medical subject headings
- Obesity, Overweight, Inflammation, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss with pharmacotherapyDrug
Some participants may receive pharmacological treatment for weight loss as prescribed by their treating physician. All interventions are part of standard clinical care and are recorded for observational analysis.
Weight loss without pharmacotherapyBehavioural
Participants receive individualized lifestyle counseling, including diet modification, physical activity recommendations, and behavioral strategies to achieve weight reduction. All interventions are part of standard clinical care and are documented for observational analysis.
| Study group | Role | What they receive |
|---|---|---|
| Overweight and Obese Adults with Cardiovascular Risk Factors | This cohort includes adult participants (≥18 years) with overweight (BMI ≥25 kg/m²) or obesity (BMI ≥30 kg/m²) and at least one cardiovascular risk factor. All participants will receive weight loss interventions, including lifestyle modifications, nutritional counseling, and/or pharmacological treatment, and will be followed longitudinally to assess changes in cardiac morphology and function, inflammatory and cardiac biomarkers, and gut microbiota composition. Receives: Drug: Weight loss with pharmacotherapy; Behavioral: Weight loss without pharmacotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Mass by Cardiac MRI
Measurement of left ventricular mass using cardiac magnetic resonance imaging to assess structural changes associated with weight loss.
Measured: Baseline, 3 months, 6 months, and 9 months.
Right Ventricular Mass by Cardiac MRI
Measurement of right ventricular mass using cardiac magnetic resonance imaging to assess structural changes associated with weight loss.
Measured: Baseline, 3 months, 6 months, and 9 months.
Left Ventricular Ejection Fraction
Assessment of left ventricular systolic function using cardiac MRI and echocardiography to detect functional changes associated with weight reduction.
Measured: Baseline, 3 months, 6 months, and 9 months.
Right Ventricular Ejection Fraction
ssessment of right ventricular systolic function using cardiac MRI and echocardiography to detect functional changes associated with weight reduction.
Measured: Baseline, 3 months, 6 months, and 9 months.
Diastolic Function Left Ventricle
Left ventricular diastolic function measuring E/A ratio using echocardiography to assess functional improvement after weight loss.
Measured: Baseline, 3 months, 6 months, and 9 months.
Diastolic Function Right Ventricle
Right ventricular diastolic function measuring E/A ratio using echocardiography to assess functional improvement after weight loss.
Measured: Baseline, 3 months, 6 months, 9 months.
Secondary outcomes (5)
Growth Differentiation Factor 15 (GDF15)
Serum GDF15 measured to assess metabolic stress and cardiovascular risk changes after weight reduction.
Measured: Baseline, 3 months, 6 months, and 9 months
Brain Natriuretic Peptide (BNP)
Serum BNP measured to assess cardiac stress and functional changes associated with weight loss.
Measured: Baseline, 3 months, 6 months, and 9 months
High-Sensitivity Troponin I
Serum high-sensitivity troponin I measured to evaluate myocardial injury or stress in relation to weight reduction.
Measured: Baseline, 3 months, 6 months, and 9 months
Galectin -3
Concentration of serum Galectin-3 in relation to cardiac fibrosis associated with weight loss.
Measured: Baseline, 3 months, 6 months, and 9 months
Gut Microbiota Composition
Fecal microbiota analysis using 16S rRNA sequencing of V3-V4 regions to assess changes in microbial diversity and composition associated with weight reduction
Measured: Baseline, 3 months, 6 months, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start20 Jun 2023
- Primary completion19 Sep 2023
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- TecSalud Investigación Clínica
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Santos y de la Garza Evia I.B.P
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455630
- Sponsor's protocol ID
- BEYOND
- Acronym
- BEYOND
- Status last verified
- Mar 2026
- First submitted
- 27 Nov 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Weight Loss on Cardiac Function and Biomarkers in Patients With Cardiovascular Risk Factors, Obesity, or Overweight
- ClinicalTrials.gov ID
- NCT07455630
- Acronym / sponsor ID
- BEYOND / BEYOND
- Conditions
- Obesity & Overweight
- Keywords
- Cardiovascular risk, Cardiac Function, Cardiac MRI, Echocardiography, Inflammation, Weight loss, GLP-1 receptor agonists
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- TecSalud Investigación ClínicaUniversity, hospital or other
- Collaborators
- Fundación Santos y de la Garza Evia I.B.P
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 19 Sep 2023 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity is a major public health problem worldwide and an established risk factor for cardiovascular disease. In individuals with obesity or overweight, systemic inflammation and endothelial dysfunction contribute to myocardial hypertrophy, ventricular remodeling, and alterations in cardiac morphology and function. Weight loss has been shown to improve metabolic and hemodynamic parameters; however, evidence regarding structural and functional cardiac reversibility remains limited.
This prospective single-center cohort study aims to evaluate changes in cardiac morphology and function (assessed by cardiac magnetic resonance imaging and echocardiography), as well as changes in inflammatory and cardiac biomarkers, in patients with obesity or overweight and cardiovascular risk factors who achieve at least a 10% reduction in body weight through pharmacological or non-pharmacological interventions.
Detailed description
Obesity is one of the leading global health issues, with a high impact on morbidity, mortality, and quality of life. In Mexico, the prevalence of obesity has significantly increased in the past two decades, ranking fifth worldwide. Obesity is strongly associated with other cardiovascular risk factors, including hypertension, diabetes, and dyslipidemia.
In obese individuals, a chronic low-grade inflammatory state and endothelial dysfunction contribute to adverse cardiovascular remodeling. These mechanisms-driven by adipose tissue inflammation, reduced nitric oxide bioavailability, and insulin resistance-can lead to myocardial hypertrophy, ventricular dilation, and impaired cardiac function. Structural and functional changes include increased left ventricular mass, larger right and left ventricular end-diastolic volumes, and subclinical diastolic dysfunction, as demonstrated by echocardiography and cardiac magnetic resonance imaging (MRI). Obesity-related adipose tissue dysfunction also induces an imbalance between anti-inflammatory adiponectin and pro-inflammatory adipocytokines, promoting myocardial and vascular remodeling.
Furthermore, epicardial adipose tissue exhibits high immune cell activity, including elevated expression of IL-1, IL-6, and TNF-α, contributing to the pathophysiology of heart failure with preserved ejection fraction (HFpEF). Alterations in gut microbiota (dysbiosis) also play a role in obesity-related inflammation by producing bacterial metabolites and lipopolysaccharides associated with endothelial activation and atherosclerotic plaque instability. Pharmacological interventions such as GLP-1 receptor agonists and SGLT2 inhibitors have shown potential benefits in reducing inflammation and improving cardiac metabolism. Weight loss-whether achieved through lifestyle modification, pharmacotherapy, or bariatric surgery-has been associated with improvements in hemodynamic load, blood pressure, and metabolic parameters. However, evidence regarding the reversibility of cardiac structural and functional changes remains insufficient. This study will prospectively evaluate adult patients (≥18 years) with overweight (BMI ≥25 kg/m²) or obesity (BMI ≥30 kg/m²) and at least one cardiovascular risk factor. Participants will receive individualized nutritional counseling and weight loss interventions (pharmacological or non-pharmacological) according to standard clinical practice at the TecSalud Institute of Cardiology and Vascular Medicine.
The primary objective is to determine whether significant weight loss (>10% reduction in body weight) results in measurable changes in cardiac morphology and function assessed by cardiac MRI and echocardiography. Secondary objectives include evaluating changes in inflammatory and cardiac biomarkers. An exploratory analysis will assess differences according to the weight loss strategy (pharmacological vs. non-pharmacological), including possible associations with gut microbiota composition. Ultimately, this study seeks to provide new evidence on the reversibility of obesity-related cardiac changes and the potential role of inflammatory and metabolic biomarkers in cardiovascular risk reduction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overweight and Obese Adults with Cardiovascular Risk Factors | – | Drug: Weight loss with pharmacotherapy, Behavioral: Weight loss without pharmacotherapyThis cohort includes adult participants (≥18 years) with overweight (BMI ≥25 kg/m²) or obesity (BMI ≥30 kg/m²) and at least one cardiovascular risk factor. All participants will receive weight loss interventions, including lifestyle modifications, nutritional counseling, and/or pharmacological treatment, and will be followed longitudinally to assess changes in cardiac morphology and function, inflammatory and cardiac biomarkers, and gut microbiota composition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with overweight or obesity and at least one cardiovascular risk factor who have been prescribed a pharmacologic or non-pharmacologic weight reduction strategy.
Key inclusion criteria (5 listed)
- Age >= 18 years
- BMI > 25 kg/m2
- At least one cardiovascular risk factor
- Has been prescribed a pharmacologic or non-pharmacologic weight loss strategy
- Signed informed consent
Key exclusion criteria (2 listed)
- No weight loss strategy prescribed
- No cardiovascular risk factors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight loss with pharmacotherapySome participants may receive pharmacological treatment for weight loss as prescribed by their treating physician. All interventions are part of standard clinical care and are recorded for observational analysis. | Drug | Overweight and Obese Adults with Cardiovascular Risk Factors |
| Weight loss without pharmacotherapyParticipants receive individualized lifestyle counseling, including diet modification, physical activity recommendations, and behavioral strategies to achieve weight reduction. All interventions are part of standard clinical care and are documented for observational analysis. | Behavioural | Overweight and Obese Adults with Cardiovascular Risk Factors |
Primary outcome
Left Ventricular Mass by Cardiac MRI
Time frame: Baseline, 3 months, 6 months, and 9 months.
Measurement of left ventricular mass using cardiac magnetic resonance imaging to assess structural changes associated with weight loss.
Right Ventricular Mass by Cardiac MRI
Time frame: Baseline, 3 months, 6 months, and 9 months.
Measurement of right ventricular mass using cardiac magnetic resonance imaging to assess structural changes associated with weight loss.
Left Ventricular Ejection Fraction
Time frame: Baseline, 3 months, 6 months, and 9 months.
Assessment of left ventricular systolic function using cardiac MRI and echocardiography to detect functional changes associated with weight reduction.
Right Ventricular Ejection Fraction
Time frame: Baseline, 3 months, 6 months, and 9 months.
ssessment of right ventricular systolic function using cardiac MRI and echocardiography to detect functional changes associated with weight reduction.
Diastolic Function Left Ventricle
Time frame: Baseline, 3 months, 6 months, and 9 months.
Left ventricular diastolic function measuring E/A ratio using echocardiography to assess functional improvement after weight loss.
Diastolic Function Right Ventricle
Time frame: Baseline, 3 months, 6 months, 9 months.
Right ventricular diastolic function measuring E/A ratio using echocardiography to assess functional improvement after weight loss.
5 secondary outcomes
Growth Differentiation Factor 15 (GDF15)
Time frame: Baseline, 3 months, 6 months, and 9 months
Brain Natriuretic Peptide (BNP)
Time frame: Baseline, 3 months, 6 months, and 9 months
High-Sensitivity Troponin I
Time frame: Baseline, 3 months, 6 months, and 9 months
Galectin -3
Time frame: Baseline, 3 months, 6 months, and 9 months
Gut Microbiota Composition
Time frame: Baseline, 3 months, 6 months, and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity & Overweight, run by TecSalud Investigación Clínica at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Mass by Cardiac MRI (time frame: Baseline, 3 months, 6 months, and 9 months.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.